Bioequivalency Study of Zidovudine Under Fed Conditions
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | June 2003 |
| End Date: | June 2003 |
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fed Conditions
The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg
tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a
single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical
history, or clinical laboratory results during screening.
Exclusion Criteria:
- Participation in a clinical trial within 30 days prior to study initiation.
- Positive blood screen for HIV or Hepatitis B and C.
- History of allergic or adverse responses to zidovudine.
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